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NCT01236053 · OUTCOME

Number of Bladder Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin

Cancer in Patients With Gabapentin (GPRD) · Source last updated 2017-07-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case

What was measured

Incident bladder cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.

Analysis population: Cases \& controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.

Groups in this outcome

Incident Bladder Cancer Patients

Patients with incident bladder cancer defined from READ/OXMIS codes in the years 1995-2008

Matched Controls for Incident Bladder Cancer Patients

Cancer-free control patients risk set matched with incident bladder cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Incident Bladder Cancer Patients4600
Matched Controls for Incident Bladder Cancer Patients43559

Reported measurements

Ever (with 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Bladder Cancer Patients15Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Bladder Cancer Patients144Not reportedNot reportedNot reportedNot reported
Never (with 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Bladder Cancer Patients4585Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Bladder Cancer Patients43415Not reportedNot reportedNot reportedNot reported
Ever (without 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Bladder Cancer Patients33Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Bladder Cancer Patients299Not reportedNot reportedNot reportedNot reported
Never (without 2 year lag)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Incident Bladder Cancer Patients4567Not reportedNot reportedNot reportedNot reported
Matched Controls for Incident Bladder Cancer Patients43260Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.58
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.69
    estimate Comment
    Comparison: "Ever (with 2 year lag)" and "Never (with 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.9614
    param Type
    Odds Ratio (OR)
    param Value
    0.99
    statistical Method
    Conditional Logistic Regression
  2. ci Lower Limit
    0.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.44
    estimate Comment
    Comparison: "Ever (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.5179
    param Type
    Odds Ratio (OR)
    param Value
    0.84
    statistical Method
    Conditional Logistic Regression
  3. ci Lower Limit
    0.71
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.48
    estimate Comment
    Comparison: "Ever (without 2 year lag)" and "Never (without 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.8856
    param Type
    Odds Ratio (OR)
    param Value
    1.03
    statistical Method
    Conditional Logistic Regression
  4. ci Lower Limit
    0.61
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.28
    estimate Comment
    Comparison: "Ever (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.5078
    param Type
    Odds Ratio (OR)
    param Value
    0.88
    statistical Method
    Conditional Logistic Regression
Complete source fields
analyses
  1. ci Lower Limit
    0.58
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.69
    estimate Comment
    Comparison: "Ever (with 2 year lag)" and "Never (with 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.9614
    param Type
    Odds Ratio (OR)
    param Value
    0.99
    statistical Method
    Conditional Logistic Regression
  2. ci Lower Limit
    0.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.44
    estimate Comment
    Comparison: "Ever (with 2 year lag)" and "Never (with 2 year lag)". Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.5179
    param Type
    Odds Ratio (OR)
    param Value
    0.84
    statistical Method
    Conditional Logistic Regression
  3. ci Lower Limit
    0.71
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.48
    estimate Comment
    Comparison: "Ever (without 2 year lag)" and "Never (without 2 year lag)".
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.8856
    param Type
    Odds Ratio (OR)
    param Value
    1.03
    statistical Method
    Conditional Logistic Regression
  4. ci Lower Limit
    0.61
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.28
    estimate Comment
    Comparison: "Ever (without 2 year lag)" and "Never (without 2 year lag)". Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.5078
    param Type
    Odds Ratio (OR)
    param Value
    0.88
    statistical Method
    Conditional Logistic Regression
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        144
    title
    Ever (with 2 year lag)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4585
      2. group Id
        OG001
        value
        43415
    title
    Never (with 2 year lag)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        299
    title
    Ever (without 2 year lag)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4567
      2. group Id
        OG001
        value
        43260
    title
    Never (without 2 year lag)
denoms
  1. counts
    1. group Id
      OG000
      value
      4600
    2. group Id
      OG001
      value
      43559
    units
    Participants
description
Incident bladder cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.
groups
  1. description
    Patients with incident bladder cancer defined from READ/OXMIS codes in the years 1995-2008
    id
    OG000
    title
    Incident Bladder Cancer Patients
  2. description
    Cancer-free control patients risk set matched with incident bladder cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
    id
    OG001
    title
    Matched Controls for Incident Bladder Cancer Patients
param Type
NUMBER
population Description
Cases \& controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.
reporting Status
POSTED
time Frame
The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case
title
Number of Bladder Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin
type
PRIMARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice